Patient Contributed Data Whitepaper

1a. Project Name Patient Contributed Data Whitepaper 1b. Project ID 1646 1c. Is Your Project an Investigative Project (aka PSS-Lite)? No 1d. Is your Project Artifact being Reaffirmed or proceeding to Normative directly after being either Informative or STU? No 1e. Today's Date 1f. Name of standard being reaffirmed 1g. Project Artifact Information 1h. ISO/IEC Standard to Adopt 1i. Does the standard include excerpted text from one or more ISO, IEC or ISO/IEC standards, but is not an identical or modified adoption? 1j. Unit of Measure 2a. Primary/Sponsor WG Patient Empowerment 2d. Project Facilitator Jan Oldenburg/Maria Moen 2e. Other Interested Parties (and roles) Patient Empowerment Community-Based Care & Privacy Workgroup Security Workgroup Mobile Health Workgroup PHR Workgroup 2f. Modeling Facilitator Not needed 2g. Publishing Facilitator Lloyd McKenzie, John Moehrke 2h. Vocabulary Facilitator Not needed 2i. Domain Expert Representative Dave deBronkart 2j. Business Requirements Analyst Jan Oldenburg, Maria Moen 2k. Conformance Facilitator Not needed 2l. Other Facilitators Virginia Lorenzi 2m. Implementers Not applicable 3a. Project Scope This project will create a white paper that explores what patient-contributed data is and is not. It will also review the standards that currently exist related to patient-contributed data. It will recommend approaches for, as well as standards that need to be developed to, appropriately represent patient-contributed data. We believe that patient-contributed data includes, but is not limited to, patient-generated health data (PGHD). Attachments 3b. Project Need Patients, and their caregivers, are the closest observers of their own health, and often have information related to their health status that should be available to treating clinicians, health records, and health information exchanges. The data represented by this information includes but is not limited to the following: personal observations and assessments of their own health & mental status; responses to health/clinical surveys; patient-recorded vital signs; patient goals, preferences, and priorities for medical treatment (goals of care); patient health readings from devices/wearables/sensors; and their own medication history (both prescription as well as non-prescription) including supplements, vitamins, OTC medications, to include such important information as noted side effects and actual patterns of medication ingestion. The presence of patient contributed data can be critical to care teams as part of understanding the patient's health condition between visits and during episodes of care, as it illuminates potentially unappreciated patterns and correlations in important information about the patient. It also acts as a facilitator for empowering the collaboration between patients and their care teams, in that it includes the patient’s own contributed information in the available data as a valued, active contributor alongside anything documented in the EHR. There are few standards governing how patient contributed data is collected, stored, transmitted, trended, or used which limits the effectiveness of this genre of data. In fact, the absence of this information can potentially lead to errors in treatment which this project seeks to address. There is also a medical culture of mistrust of data contributed by patients and families, which we seek to reduce. The standards that currently exist are underused, potentially out-dated, difficult to apply to person-centered care models of care, and reflect different understandings of what constitutes patient-contributed data than we seek to represent in this white paper. It is important that we clearly define the types of patient contributed data, understand the standards and implementation guides that already exist related to this unique dataset, and develop a plan based on discovery that provides recommendations for strategies that ensure patient-contributed data is communicated and available for use by patients, clinicians, EHR’s, researchers, and health information exchanges in a robust, standard manner. This project intersects with issues of patient consent for use of patient contributed data by the patients themselves, and/or their caregivers/proxies, the ability for patients to determine who has access to their data (which will touch on "trust" issues in a technical sense), the ability to see who has accessed their information, and a clear definition as to the intent of use by those who access the data. It also intersects with provenance tracking, in order to clearly present the source of the data and clarify whether and by whom it has been changed. We will also discuss issues around where and how this data should be stored and accessible. 3c. Security Risk No 3d. External Drivers Patient contributed health data is supported by ONC and is incorporated (very generally) in requirements for EHR vendors. It is also a factor in many devices and their specifications as well as in apps and wearables. 3e. Objectives/Deliverables and Target Dates Define the scope of what we are calling “Patient Contributed Data.” Conduct an environmental scan to identify, and review standards and implementation guides that exist in this space. Define next steps for this group based on results of the scan. This may include recommending use of existing standards, enhancement of existing standards, creating new standards and defining implementation guides. Publish 1st Ballot white paper containing all of the above in September 2022. Publish second ballot white paper in May 2023. Publish formal version in September 2023. 3f. Common Names / Keywords / Aliases: Patient Contributed Data (PCD), Patient Generated Health Data (PGHD), Patient Reported Data (PRD), Patient Reported Outcomes (PRO) 3g. Lineage 3h. Project Dependencies 3i. HL7-Managed Project Document Repository URL: https://confluence.hl7.org/display/PE/Patient+Contributed+Data 3j. Backwards Compatibility No 3k. Additional Backwards Compatibility Information (if applicable) 3l. Using Current V3 Data Types? No 3l. Reason for not using current V3 data types? White paper, N/A 3m. External Vocabularies No 3n. List of Vocabularies 3o. Earliest prior release and/or version to which the compatibility applies 4a. Products White Paper 4b. For FHIR IGs and FHIR Profiles, what product version(s) will the profiles apply to? 4c. FHIR Profiles Version 4d. Please define your New Product Definition 4d. Please define your New Product Family 5a. Project Intent White Paper 5a. White Paper Type Balloted Informative 5a. Is the project adopting/endorsing an externally developed IG? 5a. Externally developed IG is to be (select one) 5a. Specify external organization 5a. Revising Current Standard Info 5b. Project Ballot Type Informative 5c. Additional Ballot Info 5d. Joint Copyright No 5e. I understand I must submit a Joint Copyright Letter of Agreement to the TSC in order for the PSS to receive TSC approval. no 6a. External Project Collaboration Team members for this project include representatives from HL7 in Europe as well as the US. We have discussed the project with ONC team members as well as with the Mobile Health, Device, and PHR workgroups within HL7. We have also brought in multiple patients, caregivers, researchers, and academics to discuss the topic with the team and help shape the concepts and ideas for the white paper. 6b. Content Already Developed 6c. Content externally developed? 6d. List Developers of Externally Developed Content 6e. Is this a hosted (externally funded) project? 6f. Stakeholders Quality Reporting Agencies, Standards Development Organizations (SDOs), Payors, Other 6f. Other Stakeholders Patients and their proxies, surrogates, and caregivers. 6g. Vendors EHR, PHR, Health Care IT, Clinical Decision Support Systems 6g. Other Vendors 6h. Providers Emergency Services, Local and State Departments of Health, Healthcare Institutions (hospitals, long term care, home care, mental health) 6h. Other Providers 6i. Realm Universal 7d. US Realm Approval Date 7a. Management Group(s) to Review PSS 7b. Sponsoring WG Approval Date Jul 30, 2020 7c. Co-Sponsor Approval Date 7c. Co-Sponsor 2 Approval Date 7c. Co-Sponsor 3 Approval Date 7c. Co-Sponsor 4 Approval Date 7c. Co-Sponsor 5 Approval Date 7c. Co-Sponsor 6 Approval Date 7c. Co-Sponsor 7 Approval Date 7c. Co-Sponsor 8 Approval Date 7c. Co-Sponsor 9 Approval Date 7c. Co-Sponsor 10 Approval Date 7e. CDA MG Approval Date 7f. FMG Approval Date 7g. V2 MG Approval Date 7h. Architecture Review Board Approval Date 7i. Steering Division Approval Date Aug 13, 2020 7j. TSC Approval Date Apr 11, 2022